Responding to FDA Form 483s and Warning Letters

Instructor: Martha Bennett 
Product ID: 702047
Training Level: Basic to Intermediate
  • Duration: 60 Min

recorded version

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Oct-2011

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This training on responding to FDA Form 483s and Warning Letters will present methods for reviewing, evaluating, and writing responses to FDA Form 483s and Warning Letters.

Why Should You Attend:

FDA Form 483s are used to document the findings of FDA investigators or other FDA authorized inspectors after their inspection and evaluation of manufacturing and control practices associated with FDA-regulated products. Warning Letters are issued to top management of FDA-regulated companies following inspections in which the agency determines that serious violations have occurred.

Proper interpretation and understanding of the contents and phrasing of FDA Form 483 observations and Warning Letters is critical to preparing effective responses and post-inspection plans.

This course will provide examples to illustrate good techniques in reviewing and responding to FDA Form 483s and Warning Letters.

Learning Objectives:

  • Understanding of FDA Form 483
  • Understanding of Warning Letter
  • Tips for developing effective responses
  • Tips for writing effective responses

Areas Covered in the Seminar:

  • What is an FDA Form 483?
    • Purpose
    • Turbo 483
    • FDA use and processing of FDA form 483s.
  • What is a Warning Letter?
    • Purpose.
    • FDA internal instructions for issuing a Warning Letter.
    • Consequences of a Warning Letter
  • How to develop a company response?
    • Who should participate?
    • Control of information.
  • How to write a company response?
    • Who should participate?
    • Control of information.
  • Public access to FDA Form 483 and Warning Letter information.

Who Will Benefit:

  • All FDA regulated companies
  • Quality professionals
  • Regulatory affairs professionals

Instructor Profile:

Martha M. Bennett , RAC, provides a variety of regulatory affairs and quality system (GxP) consulting services to FDA regulated companies worldwide, covering foods, drugs and biologics, medical devices, and cosmetics. Based on almost forty years of experience within and outside of FDA, Martha assists companies with compliance, product development and approval, and post-marketing issues. Using risk management tools, (e.g., Six Sigma, FMEA, HACCP), Martha assists companies with validation strategy, planning and execution. Martha conducts FDA and quality focused audits and training. Thoroughly grounded and experienced in FDA law and regulations, Martha also provides consulting services to legal teams as well as expert testimony.

Martha was an FDA field investigator, senior compliance officer, and policy analyst for three FDA Commissioners. She is a board member for ASQ-FDC (American Society for Quality – Food, Drug & Cosmetic Division) and SQA (Society of Quality Assurance – Education Committee). Based on her experience and contribution to the profession, she was named a RAPS Senior Fellow.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

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